Comparison of azithromycin and co-amoxiclav in the treatment of otitis media in children.

An open randomized trial was conducted in 159 children (aged 1 to 8 years) with acute otitis media to compare the clinical efficacy of azithromycin (n = 105) and co-amoxiclav (n = 54). Azithromycin (10 mg/kg/day) was administered as a single dose for three days and co-amoxiclav was given tid for ten days at a dosage according to the manufacturer's instructions for the country. Of 103 evaluable azithromycin patients on day 3 to 5 after the start of therapy, 31 (30%) were considered cured, 67 (65%) improved and five (5%) failed compared with eight (15%) cured, 45 (83%) improved and one (2%) failed among the 54 evaluable co-amoxiclav treated patients. There was a higher number of azithromycin patients with complete resolution of symptoms at this first visit (P = 0.056). By day 10 to 12, clinical equivalence between the two treatment groups was observed with clinical cure in 86 (88%), improvement in 11 (11%) and failure in one (1%) of the 98 azithromycin patients, and in the 54 patients treated with co-amoxiclav, clinical cure was observed in 45 (83%), and improvement in nine (17%) patients. Both drugs were well tolerated and treatment related side-effects were reported in 8/105 (8%) azithromycin and 2/54 (4%) co-amoxiclav patients. In the azithromycin treatment group, these were predominantly mild to moderate gastrointestinal effects, whilst in the co-amoxiclav treatment group, both reports were of mild erythematous rash. One patient from each treatment group was withdrawn due to side-effects (azithromycin--diarrhoea and vomiting; co-amoxiclav--erythematous pruritic rash).(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes